| CTRI Number |
CTRI/2017/09/009865 [Registered on: 20/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of effects of Forsus FRD appliance therapy on lower front teeth and surrounding bone by 3-D Imaging |
|
Scientific Title of Study
|
Evaluation of root resorption, tooth inclination and cortical bone variations in mandibular anterior teeth with Forsus FRD therapy - A prospective CBCT study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Rekhawat |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
KLE Societys Institute of dental Sciences |
| Address |
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
8553003601 |
| Fax |
|
| Email |
amitsr.cricocter@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujala G Durgekar |
| Designation |
Reader |
| Affiliation |
KLE Societys Institute of dental Sciences |
| Address |
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
|
| Fax |
|
| Email |
sujala2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Rekhawat |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
KLE Societys Institute of dental Sciences |
| Address |
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore
Bangalore
KARNATAKA
560022
India |
| Phone |
8553003601 |
| Fax |
|
| Email |
amitsr.cricocter@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Amit Rekhawat
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
KLE Societys institute of dental sciences
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore 22 |
|
|
Primary Sponsor
|
| Name |
Amit Rekhawat |
| Address |
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
KLE Societys institute of dental sciences
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore 22 |
| Type of Sponsor |
Other [Self-sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Rekhawat |
KLE Societys Institute of Dental Sciences |
Department of Orthodontics and dentofacial orthopaedics
Room no. 7
22, Yeshwantpur suburb, Tumkur Main Road. Bangalore 22
Bangalore
KARNATAKA |
8553003601
amitsr.cricocter@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, Orthodontic patients undergoing treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FORSUS FRD Appliance |
A semi-rigid telescoping system that can be used in conjunction with complete fixed orthodontic appliances. FORSUS appliance is effective in correcting Class II malocclusion with a combination of skeletal and dentoalveolar effects.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Angle’s Class II malocclusion
2. Presence of fully erupted lower anterior teeth
3. No fracture and visible wear of lower incisal edges and canine tips
4. Good oral hygiene and periodontal status |
|
| ExclusionCriteria |
| Details |
1. Missing lower anteriors
2. Retained deciduous teeth
3. Dental pathology, malformations, carious lesions
4. Prosthesis on lower anteriors
5. History of previous orthodontic treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Root resorption changes in milimeters, tooth inclination changes in degrees and cortical bone variation in milimetres. |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cortical bone variation in milimetres. |
six months |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2016 |
| Date of Study Completion (India) |
20/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Turk J Orthod 2020; 33: 21-30
DOI: 10.5152/TurkJOrthod.2020.19037 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are studies for assessment of apical root resorption, tooth inclination and resultant changes in cortical bone after orthodontic treatment in general and in relation to functional appliance therapies using various radiographic modalities. But there is no study that precisely measures the effects of FORSUS appliance therapy. In most studies of OIIRR, intraoral or extraoral radiography has been used. Even with efforts to obtain periodically identical radiographs, these have shortcomings. The ability of Cone Beam Computed Tomography (CBCT) to provide distortion-free slice images of single roots provides excellent possibilities to study root resorption. As a result of the advances in CBCT and software development, dental CBCT now also offers the additional possibility of determining the topographical location of the lower incisors. |